Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) shares remained relatively muted on Monday after the firm announced a key U.S. Food and Drug Administration (FDA) approval for its gout treatment duzallo. The firm expects duzallo to be commercially available in the early fourth quarter of this year.

The FDA approval of duzallo was based on the clinical program supporting the zurampic (lesinurad) new drug application (NDA) and a pharmacokinetic study that evaluated the bioequivalence of the fixed-dose combination of lesinurad and allopurinol compared to co-administration of separate lesinurad and allopurinol tablets. The efficacy and safety of lesinurad plus allopurinol were demonstrated in two pivotal phase 3 clinical trials, which supported the Zurampic NDA.

The most common adverse reactions in clinical trials were headache, influenza, higher levels of blood creatinine (a measure of kidney function), and heartburn (acid reflux).

One import thing to point out is that duzallo has a boxed warning regarding the risk of acute renal failure. In some cases, despite approval, boxed warnings can be big deal breakers.

Michael A. Becker, M.D., professor emeritus of medicine, Department of Medicine, The University of Chicago, commented:

The approval of Duzallo provides a new fixed-dose and dual-mechanism treatment option to help patients with uncontrolled gout achieve target serum uric acid levels. This represents an important and needed new option in the treatment of hyperuricemia. Gout is a serious and potentially progressive and debilitating inflammatory disease. Getting patients with gout to serum urate goal, and keeping them at or below goal, are essential to success in treating these patients. Duzallo will help reduce the significant unmet need among patients in the U.S. who fail to get their serum uric acid levels to goal despite taking allopurinol alone.

Ultimately the stock did not have a positive response to this announcement, and for this year Ironwood has underperformed the markets. However most of this drop occurred over the summer.

Shares of Ironwood were last seen down about 0.4% at $14.44, with a consensus analyst price target of $17.59 and a 52-week range of $12.48 to $19.94.

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